Kubota Corrective Spectacles and Low Dose Atropine for Slowing Myopic Progression in Taiwanese Children
This is a bilateral, dispensing, masked, randomized clinical trial. Myopic children will be randomly assigned to one of the following: (1) Investigational clinical prototype (CP1) device without atropine, (2) Investigational CP1 device with daily instillation of 0.01% atropine, or (3) daily instillation of 0.01% atropine without use of the investigational CP1 device. Primary endpoint: Difference in the 12-month change of cycloplegic spherical refractive error and axial length between each of the three treatment groups.
• The subject must be between 6 and 13 years of age (inclusive).
• The subject must appear able and willing to adhere to the instructions set forth in the clinical protocol.
• The guardian of a minor under 18 years old must read and sign the STATEMENT OF INFORMED CONSENT and be provided a copy of the form. The subject under 18 years old must be willing to assent to the STATEMENT OF INFORMED CONSENT.
• Spherical component of refraction in the range of -0.50 to -10.00 DS in each eye.
• Refractive cylinder less than or equal to 2.00 DC in each eye (minus cylinder format).
• Best corrected distance VA of at least 20/25 in each eye.